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**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** We're looking for a **Clinical Research Associate II (CRA II)** to join our growing Clinical Operations team in **Italy**. If you're passionate about clinical research, enjoy building strong site relationships, and want to contribute to studies that make a real difference for patients worldwide, we'd love to hear from you. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ What You'll Do -------------- As a CRA II, you'll be responsible for monitoring clinical trial sites and ensuring studies are conducted in compliance with protocols, ICH-GCP guidelines, applicable regulations, and company SOPs. Your responsibilities will include: * Conducting on-site and remote monitoring visits using a Risk-Based Monitoring (RBM) approach. * Ensuring subject safety, data integrity, and protocol compliance. * Performing Source Data Verification (SDV), Source Data Review (SDR), and CRF review. * Assessing investigational product accountability through inventory and documentation reviews. * Identifying site issues, performing root cause analysis, and implementing corrective and preventive actions (CAPA). * Preparing high-quality monitoring reports and ensuring timely follow-up of action items. * Supporting site initiation, routine monitoring, and close-out visits. * Reviewing essential documents to ensure compliance with ICH-GCP and regulatory requirements. * Maintaining study documentation and updating clinical trial management systems (CTMS). * Building collaborative relationships with investigators, site staff, sponsors, and cross-functional project teams. * Supporting audit and inspection readiness throughout the study lifecycle. * Participating in investigator meetings and contributing to process improvement initiatives. * Completing administrative activities, including expense reports and timesheets, accurately and on time. What We're Looking For ---------------------- ### Required Qualifications * Master's degree in Life Sciences or an equivalent scientific qualification. * Approximately **1+ year of clinical monitoring experience** as a Clinical Research Associate or equivalent. * Good knowledge of ICH-GCP guidelines and applicable clinical research regulations. * Valid driver's license. * Fluency in **Italian and English**, both written and spoken. Skills & Competencies --------------------- ### **We're looking for someone who brings:** * Strong clinical monitoring experience. * Solid understanding of clinical trial processes and medical terminology. * Knowledge of Risk-Based Monitoring principles. * Excellent analytical thinking and problem-solving skills. * Ability to identify root causes and proactively resolve issues. * Strong communication and relationship-building skills. * High attention to detail and commitment to quality. * Excellent planning, organization, and time management abilities. * Customer-focused mindset with the ability to collaborate across diverse teams. * Flexibility and adaptability in a dynamic environment. * Proficiency in Microsoft Office and clinical systems. Working Environment ------------------- This role offers flexibility with a combination of home office, office, and clinical site-based work. The position requires: * Frequent travel to investigator sites across Italy. * Regular driving. * Occasional overnight stays. Why Join Thermo Fisher Scientific? ---------------------------------- When you join us, you'll become part of a global organization dedicated to enabling our customers to make the world healthier, cleaner, and safer. **We offer:** ------------- * The opportunity to work on innovative global clinical trials. * A collaborative and supportive international environment. * Ongoing professional development and career growth. * Exposure to leading pharmaceutical and biotechnology sponsors. * A culture that values inclusion, innovation, and excellence. If you're ready to advance your CRA career while contributing to research that changes patients' lives, we'd love to hear from you. **Apply today and make your impact with Thermo Fisher Scientific.**